Introduction SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs). Methods and analysis The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors. Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications. Trial registration number ClinicalTrials.gov: NCT05533918 and NCT05533359.
Background: Digital health interventions could be a scalable approach to delivering at-home COVID-19 testing. Objective: SCALE-UP II aimed to investigate the effectiveness of three digital health interventions on the delivery of mailed at-home COVID-19 testing: text messaging (TM), automated chatbot (CA), and patient navigation upon request (PN). Methods: Pragmatic randomized controlled trial. Participants who self-reported that they had a smartphone were randomized in a 2x2x2 factorial design (Smartphone study) to receive (i) chatbot or TM; (ii) option to request PN; and (iii) intervention frequency every 10 or 30 days. All other participants were randomized in a 2x2 factorial design (Non-Smartphone study) to receive (i) option to request PN; and (ii) intervention frequency every 10 or 30 days. Study settings were safety net community health centers (CHCs) located across the state of Utah, USA. Eligible patients were >18 years old, with a primary care visit in the last three years, and a valid cellphone in the CHC electronic health record. The primary outcome was proportion of participants requesting at-home COVID-19 tests. Results: The trial enrolled 2,117 in the Smartphone study and 31,439 in the Non-Smartphone study. In the Smartphone study, the proportion of participants who requested test kits in the Chatbot arm was lower than in TM (16.6% vs. 52.1%, aRR=0.317 [98.33% CI 0.27-0.38], P<.0001). In the Non-Smartphone study, the proportion of participants who requested test kits was higher if they were messaged every 10 days rather than every 30 days (5.5% vs 4.8%, aRR=1.144 [97.5% CI 1.03-1.28], P=.005). Yet, participants in the 10-day vs. 30-day condition were more likely to opt out of receiving study interventions (12.6% vs 7.3%, aRR=1.72 [97.5% CI 1.59-1.86], P<.0001). In the Non-Smartphone study, the proportion of participants who requested test kits was lower for those in the PN condition compared to No PN (4.3% vs 5.9%, aRR=0.729 [97.5% CI 0.65-0.81], P<.0001). Conclusions: Simple bidirectional TM was more effective than an interactive Web-based chatbot on the delivery of COVID-19 testing. Although messaging every 10 days was more effective than every 30 days, it also led to a larger opt-out rate. Digital health interventions based on automated bidirectional text messaging is a simple, scalable, and low-cost strategy to offer access to at-home COVID-19 testing. Similar approaches may be used to support public health response and other forms of at-home testing. Clinical Trial: Clinicaltrials.gov NCT05533918; https://clinicaltrials.gov/study/NCT05533918?cond=NCT05533918&rank=1 and NCT05533359; https://clinicaltrials.gov/study/NCT05533359?cond=NCT05533359&rank=1